欧洲药典EP8.0-2.6.1无菌检验-sterility中英文翻译
欧洲药典中英文翻译 EP8.0干燥失重
2.2.32. LOSS ON DRYING 干燥失重Loss on drying is the loss of mass expressed as per cent m/m.干燥失重指重量损失，表述为% 重量/重量Method. Place the prescribed quantity of the substance to be examined in a weighing bottle previously dried under the conditions prescribed for the substance to be examined. Dry the substance to constant mass or for the prescribed time by one of the following procedures. Where the drying temperature is indicated by a single value rather than a range, drying is carried out at the prescribed temperature +/- 2?C.方法：将要求数量的待检样品放置于预先干燥的称量瓶中，按要求条件进行干燥，直至样品干至恒重或下述程序指定的时长。
如果干燥温度给定的是一个值而不是一个范围，则在指定温度+/- 2?C进行干燥。
a) “in a desiccator”: the drying is carried out over diphosphorus pentoxide R at atmospheric atmostpheric pressure and at room temperature;“在干燥器中”：指在室温常压下，用五氧化二磷试剂，进行干燥b) “in vacuo”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa at room temperature;“真空”：在室温下，真空1.5kPa下，用五氧化二磷试剂进行干燥c) “in vacuo within a specified temperature range”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5kPa to 2.5kPa within the temperature range prescribed in the monograph;“在指定温度范围内真空下”：真空1.5kPa至2.5kPa下，各论要求的温度范围内，用五氧化二磷进行干燥d) “in an oven within a specified temperature range”: the drying is carrie d out in an oven within the temperature range prescribed in the monograph;“在烘箱里指定温度下”：在各论要求的温度范围内，用烘箱进行干燥e) “under high vacuum”: the drying is carried out over diphosphorus pentoxide R at a pressure not exceeding 0.1kPa, at the temperature prescribed in the monograph.“在高真空下”：在各论要求的温度下，不超过0.1kPa的真空下用五氧化二磷进行干燥If other conditions are prescribed, the procedure to be used is described in full in the monograph.如果需要采用其它条件，则在各论中应进行详细描述。
欧洲药典8.0-凡例双语版
1 GENERAL NOTICES凡例1.1 GENERAL STATEMENTS概述The General Notices apply to all monographs and other texts of the European Pharmacopoeia.凡例的内容适用于各论和欧洲药典中的其它章节。
The official texts of the European Pharmacopoeia are published in English and French. Translations in other languages may be prepared by the signatoryStates of the European Pharmacopoeia Convention. In case of doubt or dispute, the English and French versions are alone authoritative.欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。
In the texts of the European Pharmacopoeia, the word ‘Pharmacopoeia’ without qualification means the European Pharmacopoeia. The official abbreviation Ph.Eur. may be used to indicate the European Pharmacopoeia.在欧洲药典中，如无特殊规定，“药典”是指欧洲药典，官方缩写 Ph. Eur.也指欧洲药典。
The use of the title or the subtitle of a monograph implies that the articlecomplies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using themonograph title and reference number in italics.文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。
欧洲药典80纯化水微生物检测译
欧洲药典8.0纯化水微生物检测批量纯化水（区别于装在容器中的纯化水）微生物监测在生产和随后的贮存中，要采取适当措施以确保微生物数量得到适当控制和监测。
要设置适当的警戒限和行动限用于观察不良趋势。
正常条件下，微生物总数的行动限为100 CFU/mL，用薄膜过滤法，滤膜孔径不得过0.45μm，使用R2A琼脂培养基，于30-35℃培养不少于5天。
样品量的选择应与期望的检测结果相关联。
R2A琼脂培养基培养基灭菌后，调节pH7.2±0.2。
灭菌方式：高压灭菌锅，121℃、15分钟。
R2A琼脂培养基促生长试验- 试验菌株制备。
使用标准化的稳定的试验菌悬浮液，或按表0008-1所述配制。
试验用菌株的传代不得超过5代，从菌种保藏中心获得的原始菌株算起。
按表0008-1所述，每个菌株分开培养。
使用pH7.0氯化钠-蛋白胨缓冲液或pH7.2磷酸盐缓冲液配制试验菌悬浮液。
试验菌悬浮液配制好后，应在2小时内使用，或存于2-8℃于24小时内使用。
作为一种替代方法，可以配制然后稀释枯草芽孢杆菌（Bacillus subtilis）生长细胞的新鲜悬浮液：配制一个稳定的孢子悬液，然后使用适当体积的孢子悬液用于试验接种。
孢子悬液可在2-8℃贮藏，贮藏时间要经过验证。
- 促生长。
每批已配制好的培养基都要做促生长试验，不管是使用脱水培养基（干粉）配制，还是使用上述的成分配制。
将表0008-1所述的微生物取少量（不超过100CFU），单独接种至含R2A琼脂培养基的平皿中，按表中所述的条件培养。
培养后观察到的微生物结果不得超过理论值±2倍。
针对新配制的接种体，微生物促生长试验结果必须与之前试验过、批准过的培养基结果做对比。
表0008-1R2A琼脂促生长试验微生物试验菌株制备促生长条件。
欧盟GMP-术语-中英文版
GLOSSARY术语Definitions given below apply to the words as used in this guide. They may have different meanings in other contexts.以下所列定义适用于本指南中所用词汇，在其他上下文中同一术语的涵义可能不同。
AIR-LOCK气锁An enclosed space with two or more doors, and which is interposed between two or more rooms, e.g. of differing class of cleanliness, for the purpose of controlling theair-flow between those rooms when they need to be entered. An air-lock is designed for and used by either people or goods.设置于两个或数个房间之间(如不同洁净级别的房间之间)的具有两扇或多扇门的隔离空间。
设置气锁的目的是在人员或物料出入其间时，对气流进行控制。
气锁有人员气锁和物料气锁之分。
BATCH (OR LOT)批A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.由一个或若干加工过程生产的具有预期均一质量和特性的一定数量的原辅料、包装材料或药品。
NoteTo complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogeneous batch. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterised by its intended homogeneity.注：为完成某些生产操作步骤，可能有必要将一批分成若干亚批，然后再合起来成为一个最终均一的批。
ep8.02.6.13非无菌药品的微生物限度检查：特殊微生物的检查(中英对照)
EP 8.004/2010:20613 MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS(3)非无菌药品的微生物限度检查：特殊微生物的检查1. INTRODUCTION 导言The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described.下述检验方法用于检查在描述的试验条件下特定微生物的定性及限度。
The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below.检验的主要目的是为了确定是否原料药或制剂符合已建立的微生物限度标准，当用于这一目的时，应按照以下方式（包括取样量），进行并按照下述描述对结果进行分析。
Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopoeia method has been demonstrated.如果可证明某种试验方法（包括自动化分析法）的效果与药典中的方法等同，该方法可作为另一种供选择的试验方法。
欧盟GMP中英文对照
实用文档European Union药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS目录第一章质量管理CHAPTER 1: QUALITY MANAGEMENT原则............................................................ ..................................................... ............ (5)Principle (5)质量保证................................................................... .............. . (5)Quality Assurance (5)药品生产质量管理规范(GMP) (7)Good Manufacturing Practice for Medicinal Products (7)质量控制(QC) (9)Quality Control....................... . (9)产品质量回顾....................... ....................... (10)第二章人员CHAPTER 2: PERSONNEL...................................................................................... .. (11)原则 (11)Principle (11)通则 (12)General...................................................................................................................... . (12)关键人员................................................................................................................... . (12)Key Personnel (12)培训 (12)Training..................................................................................................................... . (15)人员卫生 (16)Personnel Hygiene (16)第三章厂房和设备CHAPTER 3: PREMISES AND EQUIPMENT................................................................ .. (18)原则 (18)Principle (18)厂房 (18)Premises (18)通则 (18)General (18)生产区 (19)Production Area (19)贮存区 (21)Storage Area (21)Quality Control Area (22)附助区 (22)Ancillary Areas (22)设备 (23)Equipment (23)第四章文件CHAPTER 4: DOCUMENTATION (24)原则 (24)Principle (24)通则 (25)General (25)文件要求 (27)Documents Required (27)Specifications (27)Specifications for starting and packaging materials (27)Specifications for Intermediate and Bulk Products (27)Specifications for Finished Products (28)Manufacturing Formulae and Processing Instructions (28)Packaging Instructions (30)Batch Processing Records (31)Batch Packaging Records. (32)Procedures and Records........................................................................................ .. (33)Receipt (34)Sampling (34)Testing (35)Other (35)第五章生产CHAPTER 5: PRODUCTION......................................... ........ (36)原则........................................ . (36)Principle (36)通则........................................ . (36)General (36)生产过程中对交叉污染的预防 (39)Prevention of Cross-contamination in Production (39)Validation................................. . (40)原料........................................ . (41)Starting Materials..................... . (41)生产操作：中间产品和待包装产品 (42)Processing Operations: Intermediate and Bulk Products (42)包装材料........................................ . (43)Packaging Materials.......................... . (43)包装操作........................................ . (44)Packaging Operations........................ . (44)成品........................................ . (46)Finished Products..................... . (46)不合格、回收料和退货物料 (46)Rejected, Recovered and Returned Materials (46)第六章质量控制CHAPTER 6: QUALITY CONTROL (48)原则........................................ . (48)Principle................................... . (48)通则........................................ . (48)General... .. (48)质量控制实验室规范 (49)Good Quality Control Laboratory Practice (49)Documentation (49)Sampling................................... (50)Testing... .. (52)销售产品的稳定性考察 (54)第七章委托生产与委托检验CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS (55)原则........................................ . (55)Principle................................... . (55)通则........................................ . (56)General..................................... . (56)委托方.................................... . (56)受托方.................................... (57)The Contract Acceptor.............. (57)合同........................................ . (58)The Contract............................. (58)第八章投诉与召回CHAPTER 8: COMPLAINTS AND PRODUCT RECALL (59)原则........................................ . (59)Principle.................................... . (59)投诉........................................ . (59)Complaints................................ . (59)召回 (60)Recalls (60)第九章自查CHAPTER 9: SELF INSPECTION (61)原则 (61)Principle (61)附件8 原辅料和包装材料的取样ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS (63)原则 (63)Principle (63)人员 (63)Personnel (63)原辅料 (63)Starting materials (64)包装材料 (65)Packaging material (65)第一章质量管理CHAPTER 1 QUALITY MANAGEMENTPrinciple原则生产许可证持有厂家只能生产医药产品，以确保药品符合其预期的使用目的，符合销售许可证的要求，并不因药品安全性、质量或药效方面的问题而给患者带来风险。
EUGMP-中英文对照[1]
![EUGMP-中英文对照[1]](https://img.taocdn.com/s3/m/a56c582fd1f34693dbef3e0d.png)
EU GMP ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS （中英文对照）(a) These are average values. （一）这些都是平均值。
(b) Individual settle plates may be exposed for less than 4 hours. （二）单个沉降皿放置的时间可以少于4小时。
20. Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action。
对尘埃粒子和微生物的监控结果，要设置适当的警戒限度和行动限度。
当超出这些限度时，操作规程应说明需要采取的措施。
Isolator technology 隔离技术21. The utilisation of isolator technology to minimize human interventions in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment. There are many possible designs of isolators and transfer devices. The isolator and the background environment should be designed so that the required air quality for the respective zones can be realised. Isolators are constructed of various materials more or less prone to puncture and leakage. Transfer devices may vary from a single door to double door designs to fully sealed systems incorporating sterilization mechanisms. 在生产区采用人员方面的隔离技术，在无菌产品的生产中，会显著降低周围环境微生物污染的风险。
欧盟GMP附录1(征求意见稿)无菌药品-中英文对照
Annex 1 Manufacture of Sterile Medicinal Products 附录1 无菌药品的生产Document map文件结构图Section Number 章节号General overview 总览1. Scope 1.范围Additional areas (other than sterile medicinal products) where the general principles of the annex can be applied.可适用附录总则的额外区域（无菌药品除外）2. Principle 2.原则General principles as applied to the manufacture of medicinal products. 适用于药品生产的总体原则。
3. Pharmaceutical Quality System (PQS) 3.制药质量体系（PQS）Highlights the specific requirements of the PQS when applied to sterile medicinal products.强调应用于无菌药品时，PQS的具体要求。
4. Personnel 4.人员Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel.有关具体培训、知识和技能要求的指南。
也提供人员确认指南。
5. Premises 5.厂房General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of barrier technology.有关厂房设计的具体需求的总体指南，以及有关厂房确认（包括屏障技术的使用）的指南。
2015版英国药典灭菌法的翻译
Appendix XVIII Methods of Sterilisation(Ph. Eur. general texts 5.1.1)Sterility is the absence of viable micro-organisms. The sterility of a product cannot be guaranteed by testing; it has to be assured by the application of a suitably validated production process. It is essential that the effect of the chosen sterilisation procedure on the product (including its final container or package) is investigated to ensure effectiveness and the integrity of the product and that the procedure is validated before being applied in practice. It is recommended that the choice of the container is such as to allow the optimum sterilisation to be applied. Failure to follow meticulously a validated process involves the risk of a non-sterile product or of a deteriorated product. Revalidation is carried out whenever major changes in the sterilisation procedure, including changes in the load, take place. It is expected that the principles of good manufacturing practice (as described in, for example, the European Community Guide to GMP) will have been observed in the design of the process including, in particular, the use of:无菌性是没有存活的微生物。
欧盟GMP(中英文对照)
（The words that are in the green background are new standards）(绿色背景下的内容为新标准)ANNEX 1MANUFACTURE OF STERILE MEDICINAL PRODUCTS附录1 无菌医药产品的生产Principle总则The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test.无菌药品的生产，必须符合一些特殊的要求，以防止微生物、微粒和热源的污染。
这很大程度上依赖与工作人员的技术水平、培训和工作态度。
在这方面质量保证显得特别重要，这种类型的生产，必须严格按照完善的和经过验证的生产方法和工作程序。
仅靠产品的最终灭菌和某一方面的质量控制是不允许的。
欧洲药典EP8.0-2.6.1无菌检验-sterility中英文翻译
欧洲药典EP8.0-2.6.1无菌检验-sterility中英文翻译2.6.1. STERILITY2.6.1 无菌检查法The test is applied to substances, preparations or articles which, accordingto the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test.本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。
但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。
PRECAUTIONS AGAINST MICROBIAL CONTAMINATION微生物污染防范The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls.无菌检测试验应在无菌的条件下进行。
EP8.0细菌内毒素检查法中英文对照
EP8.0 2.6.14 细菌内毒素（中英文）2.6.14. BACTERIAL ENDOTOXINS 细菌内毒素The test for bacterial endotoxins (BET) is used to detect or quantify endotoxins from gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphenmus or Tachypleus tridentatus). There are 3 techniques for this test: the gel-clot techniques, which is based on gel formation; the turbidimetric technique, based on the development of turbidity after cleavage of an endogenouse substrate; and the chromogenic technique, based on the development of colour after cleavage of a synthetic peptide-chromogen complex.本法利用鲎试剂（从鲎——美洲鲎或中国鲎——变形细胞溶解物制备而来）检测由革兰氏阴性菌产生的细菌内毒素或对内毒素进行定量。
该检查包括三种方法：一为凝胶法，系利用鲎试剂与内毒素产生凝集反应的原理；第二种为浊度法（基于内源性底物断裂后，产生的浊度变化）；最后一种为显色法（得到的肽－呈色基团复合物断裂后，检测反应混合物的色度）。
The following 6 methods are described in the present chapter:这一章阐述了下面6种方法：Method A. Gel-clot method: limit testMethod B. Gel-clot method: quantitative testMethod C. Turbidimetric kinetic methodMethod D. Chromogenic kinetic methodMethod E. Chromogenic end-point methodMethod F. Turbidimetric end-point method方法A：凝胶法：限度试验方法B：凝胶法：定量试验方法C：动态浊度法方法D：动态显色法方法E：终点显色法方法F：终点浊度法Proceed by any of the 6 methods for the test. In the event of doubt or dispute, the final decision is made based upon method A unless otherwise indicated in the monograph.检测时，可用6种方法的任一种进行试验。
纯化水英汉对照-欧洲药典8.0
WATER,PURIFIED纯化水H2O M r18.12 DEFINITIONWater for the preparation of medicines other than those that are required to be both sterile and apyrogenic,unless otherwise justified and authorized.定义制药用水不同于其它用水，要求它是无菌的、无热源的，除非另有调整或授权。
Purified water in bulk散装纯化水PRODUCTIONPurified water in bulk is prepared by distillation,by ion exchange,by reverse osmosis or by any other suitable method from water that complies with the regulations on water intended for human consumption laid down by the competent authority.Purified water in bulk is stored and distributed in conditions designed to prevent growth of micro-organisms and to avoid any other contamination.生产：散装纯化水是经合格的当局规定的适宜人类使用的水经蒸馏、离子交换、反渗透膜或其他任何适合的方法制备。
散装纯化水存储和分配于可防止微生物生长和可避免其他任何污染的条件下。
Microbiological monitoring During production and subsequent storage, appropriate measures are taken to ensure that the microbial count is adequately controlled and monitored.Appropriate alert and action levels are set so as to detect adverse trends.Under normal conditions,an appropriate action level is a microbial count of100CFU/mL,determined by filtration through a membrane with a nominal pore size not greater than0.45μm,using R2A agar and incubating at30-35°C for not less than5days.The size of the sample is to be chosen in relation to the expected result.微生物监测在生产和其后的存储过程中，采取适当的方式以确保水的微生物数受到足够的控制和监测。
[EP}EP6 2.6.1 无菌检查 中文版
2.6 生物检查2.6.1 无菌检查无菌检查法系用于检查药典要求无菌的生物制品、医疗器具、原料、辅料及其他品种是否无菌的一种方法。
若供试品符合无菌检查法的规定，仅表明了供试品在该检验条件下未发现微生物污染。
在本文的最后，有如何采用检查法检查无菌的指导。
微生物污染的预防无菌检测试验应该在无菌的环境下进行。
通过预防，我们可以避免微生物对试验的污染。
同时，这些预防也应该不会对检查的微生物有影响。
工作的环境应该定期进行检查，进行合适的对照试验（遵循比如欧共体指示中的或GMP中的要求）。
培养基及孵化温度培养基可按以下处方制备，亦可使用按该处方生产的通过生长促进试验的现成的培养基。
以下培养基适用于无菌检查。
硫乙醇酸盐流体培养基是厌氧菌检查的首选培养基，同时，它也可用于需氧菌检查。
大豆消化酪蛋白脉琼脂培养基适用于霉菌和需氧菌检查。
也可以使用。
其他通过细菌生长促进试验以及验证试验的培养基。
硫乙醇酸盐流体培养基L -胱氨酸 0.5克 颗粒琼脂（水分含量不超过百分之十五） 0.75克 氯化钠 2.5克 葡萄糖 一水/无水 5.5克/5.0克 酵母膏（水溶性） 5.0克 胰酶蛋白胨 15.0克 琉基乙酸钠 0.5克 或琉基乙酸 0.3毫升 新配制的刃天青钠溶液 1.0毫升 （1 g / L的 刃天青钠）纯水 1000毫升 灭菌后培养基的pH值应为 7.1 ± 0.2将L -胱氨酸、琼脂、氯化钠、葡萄糖、酵母膏以及胰酶蛋白脉与纯水混合，加热至完全溶解。
然后往溶液中加入琉基乙酸钠或琉基乙酸使溶解，必要时，加入1M氢氧化钠调节溶液的pH，使灭菌后的pH 值为7.1士0.2。
如需过滤，再次加热溶液不必沸腾，趁热用浸湿的滤纸过滤，加刃天青钠溶液并混和均匀，将培养基转移至适宜的可给出培养基表面深度比例的容器中，这样，在培养期结束时，显示的氧化层颜色变化不得超过培养基深度的1/2。
采用有效的方法对培养基进行灭菌。
如果贮存，应贮存在温度介于2-25℃、无菌密闭的容器中。
欧洲药典8.0-凡例双语版
1 GENERAL NOTICES凡例1.1 GENERAL STATEMENTS概述The General Notices apply to all monographs and other texts of the EuropeanPharmacopoeia.凡例的内容适用于各论和欧洲药典中的其它章节。
The official texts of the European Pharmacopoeia are published in English andFrench. Translations in other languages may be prepared by the signatoryStates of the European Pharmacopoeia Convention. In case of doubt or dispute,the English and French versions are alone authoritative.欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。
In the texts of the European Pharmacopoeia, the word ‘Pharmacopoeia’ without qualification means the European Pharmacopoeia. The official abbreviation Ph.Eur. may be used to indicate the European Pharmacopoeia.在欧洲药典中，如无特殊规定，“药典”是指欧洲药典，官方缩写 Ph. Eur.也指欧洲药典。
The use of the title or the subtitle of a monograph implies that the articlecomplies with the requirements of the relevant monograph. Such references tomonographs in the texts of the Pharmacopoeia are shown using themonograph title and reference number in italics.文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。
EP 8.0-2.6.13 非无菌药品的微生物限度检查：特殊微生物的检查(中英对照)
EP 8.004/2010:20613 2.6.13. MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS(3)非无菌药品的微生物限度检查：特殊微生物的检查1. INTRODUCTION 导言The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described.下述检验方法用于检查在描述的试验条件下特定微生物的定性及限度。
The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below.检验的主要目的是为了确定是否原料药或制剂符合已建立的微生物限度标准，当用于这一目的时，应按照以下方式（包括取样量），进行并按照下述描述对结果进行分析。
Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopoeia method has been demonstrated.如果可证明某种试验方法（包括自动化分析法）的效果与药典中的方法等同，该方法可作为另一种供选择的试验方法。
无菌活性物质的适应性证书-中文
Certification UnitCP/CBPPUBLIC DOCUMENT(Level 1)English/ChinesePA/PH/Exp.CEP/T(06)13, 1RStrasbourg, July 2004 Certification of suitability of Monograph of the European Pharmacopoeia欧洲药典适应性证书Certificate of suitability for sterile active substances无菌活性物质的适应性证书Publication on the website and implementation PA/PH/Exp.CEP/T(06)13 15 April 2006 Corrected version: publication on the websitePA/PH/Exp.CEP/T(06)13, 1R August 2006and implementation网站公布和执行PA/PH/Exp.CEP/T(06)13 2006年4月15日更正版：网站公布和执行PA/PH/Exp.CEP/T(06)13, 1R 2006年8月Certificate of suitability for sterile active substances无菌活性物质的适应性证书It is possible to apply for a certificate of suitability for a sterile active ingredient. The conditions and procedures for this option have been defined and are described below:可以申请无菌活性成份的欧洲药典适用性证书。
申报的前提和具体要求如下：- The substance shall be sterile and shall comply with the test for sterility 2.6.1 described in the European Pharmacopoeia.- 必须无菌，并符合EP2.6.1无菌检验要求- The sterilization process shall be described in detail in the application, together with full data on the validation of the sterilization method.- 申报文件必须详细描述灭菌工艺过程，必须同时提供该灭菌方法的完整验证资料- The company shall refer to suitable GMP rules. The Good Manufacturing Practice for Active Pharmaceutical Ingredients (ICHQ7A)only applies to the manufacture of sterile active pharmaceutical ingredients (APIs) up to the point immediately prior to the APIs being rendered sterile. The sterilisation and aseptic processing of sterile APIs are not covered by this guideline and shall be performed in accordance with GMP for medicinal products (Commission Directive 2003/94/EC of 8 October 2003, laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and investigational medicinal products for human use, or equivalent). When a company applies for a certificate of suitability for a sterile active ingredient, declarations referring to appropriate GMP covering the sterilisation steps and subsequent aseptic handling are to be provided. Depending on the legislation in force in the country in which the manufacturer is located these steps may be subject to the holding of a manufacturing authorization or establishment license, and/or subject to regular inspections by a regulatory authority for medicinal products.- 公司必须符合合适的GMP规定。
灭菌、消毒的相关术语及英文释译
灭菌、消毒的相关术语及英文释译1.灭菌(Sterilization)：灭菌是杀灭或除去外环境中一切微生物的过程。
这里所说的一切微生物包括一切致病的和非致病的微生物，也包括细菌芽胞、真菌孢子。
灭菌是个绝对的概念，意为完全杀死或除掉外环境中的一切微生物。
然而事实上要达到这样的程度是不可能的，因此目前国际上规定，灭菌过程必须使物品污染的微生物存活概率减少到10-6，换句话说，若对100万件物品进行灭菌处理，灭菌后只容许有一件物品中存留活的微生物。
在医疗用品中，凡是输入病人体内的血液和其他液体及进入无菌组织和无菌体腔的器材，都必须达到灭菌。
2. 灭菌剂（sterilant）和灭菌器（sterilizer）：灭菌剂是可杀灭一切微生物(包括细菌芽孢)使其达到灭菌要求的化学或生物制剂。
灭菌器是利用物理、化学或生物杀菌因子制备的、用于灭菌的器械。
3. 消毒(Disinfection)：消毒是杀灭或去除外环境中病原微生物的过程。
这里所说的“外环境”在外国，仅指无生命的物体和表面，但在我国，一般认为除包括液体、气体和固体物体外，也包括有生命机体的体表和表浅体腔。
这里所说的“病原微生物”，包括除细菌芽胞以外的各种致病性微生物。
例如：细菌繁殖体、真菌、病毒、立克次体、衣原体等。
消毒并不要求杀灭或去除污染物体的全部病原微生物，而是使其减少到不至于引起疾病的数量。
一般来说，在医用器材和医疗环境的消毒中, 若能使人工污染在载体上的微生物在消毒过程中的存活概率减少到10-3，就可以了。
换句话说，通过消毒处理后，杀灭或去除了原有微生物的99.9％，也就达到了消毒要求。
若用消毒对象上污染的自然微生物的杀灭率来评定消毒效果，一般以杀灭或清除率达到90％为合格。
4. 消毒剂（disinfectant）和消毒器（disinfector）：消毒剂是用于杀灭传播媒介上的病原微生物使其达消毒或灭菌要求的制剂，包括化学制剂和生物制剂。
消毒器是利用物理、化学或生物杀菌因子制备的、用于消毒的器械。
欧洲药典8。0翻译
欧洲药典8.0版3.1 用于包装容器生产的材料这一章描述的是用于药物包装容器生产的材料。
可能还用于部分或全部医疗手术器材的生产。
未包含在药典中的材料或聚合物的使用取决于主管当局的审批。
3.1.6聚丙烯用于注射液和眼用药的包装容器和包装塞定义聚丙烯是由丙烯单独聚合、或者由丙烯、乙烯（不超过25%）共同聚合而成，或者为聚丙烯、聚乙烯（不超过25%）的混合物，这些物质包含他们的同类高聚合物（C4-C10）或者羧酸或者酯类并且不超过25%。
可能含有添加剂。
成品聚合物中会添加一些特定的添加剂以使他们的化学、物理和机械性能更优，以适应预期用途。
所有这些添加剂均选自附件列表，并给出了每个产品中的最大允许含量。
产品中最多只能含有3种抗氧化剂，一种或更多润滑剂或者抗粘连剂，当材料必须提供遮光功能时，还要添加二氧化钛作为遮光剂。
—塑料添加剂07[128-37-0] 丁基羟基甲苯butylhydroxytoluene 抗氧剂BHT 限量：0.125%；—塑料添加剂09[6683-19-8] 四[β-（3，5-二叔丁基-4-羟基苯基）丙酸]季戊四醇酯[pentaerythritol tetrakys 3-(3,5-ditert-butyl-4-hydroxyphenyl )propionate] 抗氧剂1010限量：0.3%；—塑料添加剂13[27676-62-6] 1,3,5-三(3,5-二叔丁基-4-羟基苄基)-顺式-三嗪-2,4,6(1H,3H,5H)-三酮限量：0.3%；—塑料添加剂11[2082-79-3] 3-(3,5-二叔丁基-4-羟基苯基)丙酸正十八碳醇酯octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate 抗氧剂1076 限量：0.3%；—塑料添加剂08[32509-66-3] 3-(1,1-二甲基乙基)-β-[3-(1,1-二甲基乙基)-4-羟苯基]-4-羟基-β-甲基苯甲酸-1,2-亚乙基酯Ethylene bis[3,3-bis[3-(1,1-dimethylethyl)-4-hydroxyphenyl]butanoate] 限量：0.3%；—塑料添加剂15[2500-88-1] 二(十八烷基)二硫化物dioctadecyl disulfide限量：0.3%；—塑料添加剂10[1709-70-2] 2,2′,2″,6,6′,6″-己烷-叔丁基-4,4′,4″-[(2,4,6-三甲基-1,3,5-苯基)三亚甲基]三苯酚2,2′,2″,6,6′,6″-hexa-tert-butyl-4,4′,4″-[(2,4,6-trimethyl-1,3,5-benzenetriyl)trismet hylene] triphenol 抗氧剂330 限量：0.3%；—塑料添加剂14[3806-34-6] 2，2′-二（十八烷基氧）-5，5′-螺[1，3，2-二氧亚磷酸酯]2,2′-bis(octadecyloxy)-5,5′-spirobi[1,3,2-dioxaphosphinane] 限量：0.3%；—塑料添加剂16[123-28-4] 二（十二烷基）3，3′-硫代二丙酸盐didodecyl 3,3′-sulphanediyldipropanoate限量：0.3%；—塑料添加剂17[693-36-7] 硫代二丙酸双十八酯dioctadecyl3,3′-thiodipropionate抗氧剂DSTOP 限量：0.3%；—塑料添加剂12[31570-04-4] 三(2,4-二叔丁基苯基) 亚磷酸酯tris(2,4-di-tert-butylphenyl) phosphate 抗氧剂168 限量：0.3%；以上抗氧化剂总含量不得超过0.3%。
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2.6.1. STERILITY
2.6.1 无菌检查法
The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test.
本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。
但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。
PRECAUTIONS AGAINST MICROBIAL CONTAMINATION
微生物污染防范
The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls.
无菌检测试验应在无菌的条件下进行。
为了达到这样的条件，检测环境应当与无菌检测的操作要求相适应。
避免污染的防范措施应当不对本检查方法进行检测的微生物造成影响（应并不影响用本检查法检测的微生物）。
通过对工作区域的适当取样以及进行适当的控制来对无菌检查的工作环境进行例行监测。
CULTURE MEDIA AND INCUBATION TEMPERATURES
培养基和培养温度
Media for the test may be prepared as described below, or equivalent commercial media may be used provided that they comply with the growth promotion test.
应按下面描述的方法制备无菌检查的培养介质，如果满足生长促进试验要求，与本处所述培养基相当的商业化培养基也可以采用（也可采用与本处……）。
The following culture media have been found to be suitable for the test for sterility. Fluid thioglycollate medium is primarily intended for the culture of
anaerobic bacteria; however, it will also detect aerobic bacteria. Soya -bean casein digest medium is suitable for the culture of both fungi and aerobic bacteria.
下述的培养基已被证明（经证明）适用于无菌检查。
硫乙醇酸盐流体培养基主要用于厌氧菌培养，但是，也适用于需氧菌检测。
大豆酪蛋白消化物培养基适用于真菌和需氧菌培养。
and pancreatic digest of casein with the water R and heat until solution is effected.。